BEUDAMED
    98 results · 12ms · Sources: EU EUDAMED, US FDA

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    Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

    FDA Recall
    Terminated ·MEDTRONIC ATS MEDICAL, INC.·Product code LWQ·February 11, 2020

    On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The On-X Prosthetic Heart Valve is available in 3 aortic configurations. All aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. Aortic valves, size 19 mm through 25 mm, are designed for intrasupra-annular sewing ring position, while the valve size 27/29 mm is designed for intra-annular sewing ring position. All mitral valve sizes are designed for the supra-annular sewing ring position.

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code LWQ·January 17, 2019

    On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code LWQ·June 12, 2015

    ATS Open Pivot Mechanical Heart Valve

    FDA Recall
    Terminated ·ATS Medical, Inc.·Product code LWQ·February 18, 2004

    TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·September 5, 2012

    Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012

    5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·November 28, 2012